What is EU Medical Device Classification?
According to MDR 2017/745, Article 51 of the EU Medical Device Classification categorizes medical devices into classes I, IIa, IIb, and III, considering their intended purposes and their inherent risks. The risk is incremental from class I to class III. The Medical Device Directive (MDD) and Medical Device Regulation (MDR) both use a rule-based classification pattern for medical devices. In the new MDR, there are now 22 rules in Annex VIII.
The determination of the medical device classification and the corresponding classification rule is the first step in the EU CE marking process. Based on the class and the rule of the device, the technical file and the Notified Body application can be filed.
EU Medical Device Classification with Examples!
Class 1 - Low Risk
- Examples: corrective glasses and frames; manual wheelchairs
- Type of Certification: Self-Certification or Self-Declaration
Class 1s Low Risk (Sterile)
- Examples: personal protection kits, sterile urine bags, etc.
- Type of Certification: Notified Body
Class 1m Low Risk (Measuring Body attributes)
- Examples: stethoscopes, weighing balance
- Type of Certification: Notified Body
Class 1r Low Risk ( Reused Device)
- Examples: Surgical forceps (all types of SS/TIT surgical equipment sterilized and reused by hospitals)
- Type of Certification: Notified Body
Class IIa - Medium Risk
- Examples: orthodontic wires, surgical gloves, lancets
- Type of Certification: Notified Body
Class IIb - Medium to High Risk
- Examples: orthopedic nails and plates; intra-ocular lenses; incubators for babies
- Type of Certification: Notified Body
Class III - High Risk
- Examples: pacemakers, prosthetic heart valves, cardiovascular sutures, brain spatulas, drug-device combination products
- Type of Certification: Notified Body
EU Medical Device Classification Rules!
As per Annex VIII of the EU MDR Medical Device Classification Rules, they are as follows:
- Rules 1–4: Non-invasive Devices
- Rules 5–8: Invasive Devices
- Rules 9–13: Active Devices
- Rules 14–22: Special Rules
I3CGLOBAL Scope
I3CGLOBAL successfully completed 300+ CE certifications worldwide by supporting manufacturers with device classification of simple and complex device technologies for faster NB approval. We have offices in India, Europe, and the USA to help with classification and technical documentation.